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Home > Dail Eireann debate. Topical issues debate - Cannabis for medicinal use.

[Oireachtas] Dail Eireann debate. Topical issues debate - Cannabis for medicinal use. (05 Dec 2019)

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Deputy Gino Kenny: I am grateful this Topical Issue matter has been taken. The subject, access to medicinal cannabis where there is a medical need, has caught the Irish public's imagination over the past three and a half years. I have been quite vocal about it. The Minister of State will have to agree that this has been a very protracted process to provide legal access to medicinal cannabis in Ireland. Three years ago almost to the day, the majority of Deputies voted to allow the regulation of cannabis Bill I introduced go forward. That was a milestone in this debate on access to medicinal cannabis. Time is of the essence for people who need this medication. Over the period since that milestone, people have been forced to go abroad, to go to the black market or to go without. It is quite galling that people to whom this could be beneficial have to go without. The announcement last week that two cannabis-based products will be rescheduled will not make a major difference to most. People will still be forced to go abroad under licence, to go to the black market and to go without. …….


Minister of State at the Department of Health (Deputy Catherine Byrne): I am taking this on behalf of the Minister, Deputy Harris. I apologise to the Deputy that the Minister could not be here. Before I read the statement, I commend the Deputy on his resilience in bringing this topic to the floor of the House over the past year. People can now access medical cannabis but it has to be prescribed.


On 26 June the Minister signed legislation, which allows for the operation of the MCAP on a pilot basis for five years. This new legislation means that commercial medical cannabis suppliers whose cannabis products meet the specified requirements set out in the legislation and have been listed in Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations will be able to supply these products to the Irish market via an Irish-based authorised wholesaler.


Once suitable medical cannabis products are made available by suppliers, the access programme will make it possible for a medical consultant to prescribe, in line with the published clinical guidance, a listed cannabis-based product for a patient under his or her care for the following medical conditions: where the patient has failed to respond to standard treatments; spasticity associated with multiple sclerosis; intractable nausea and vomiting associated with chemotherapy; and severe, refractory, treatment-resistant, epilepsy. Cannabis products will only be listed in the Schedule to the legislation once they have been accepted as meeting the criteria for such products to be added to Schedule 1 of the regulations underpinning the access programme. Based on the information provided by applicants, two cannabis-based products have been deemed by the Health Products Regulatory Authority, HPRA, to have met the applicable criteria set out in the legislation. These two products are Aurora high CBD oil drops from Aurora Cannabis Enterprises and CannEpil from MGC Pharmaceuticals. The Minister has accepted the HPRA's advice and the products have been added to Schedule 1 of the legislation. As these products will be subject to international export licensing requirements, which are outside the control of the Department of Health, they are not expected to be available in Ireland for a further period. It will be the decision of the treating medical consultant, in consultation with his or her patient, to prescribe a cannabis-based treatment for a patient under his or her care.


Pending full operation of the access programme, doctors may continue to apply through the ministerial licensing route for a licence to prescribe medical cannabis for an individual patient under their care. Sixty-six licences have now been granted in respect of 31 individual patients. Departmental officials and the HSE will meet next week to finalise plans for the MCAP patient register and reimbursement procedures. In the interim, the HSE has advised that for an application to be considered for reimbursement approval, prescribers must submit a valid medical prescription for the prescribed cannabis product, provide a copy of the ministerial licence, and the patient must have sourced and positively responded to the cannabis-based product. If approval is given, the primary care reimbursement service, PCRS, when authorised to proceed, will make the necessary arrangements to cover the costs involved for the patient.


The HSE has advised that in the previous situations where it considered reimbursement support appropriate, a number of steps were completed. The patient's consultant should be satisfied that all therapeutic options have been exhausted and be prepared to accept the responsibility for monitoring the patient's response to the cannabis product. A prescriber then applies to the Minister for a ministerial license and, following consideration, a ministerial licence may be granted. The consultant then completes an individual reimbursement form, setting out the therapeutic benefits for the patient. It is important that this is completed in sufficient detail for therapeutic benefit to be demonstrated. The individual's reimbursement form is considered by the medicines management programme, MMP. On review of the documentation, the MMP makes a recommendation for or against reimbursement support for the patient to the HSE, under the patient's eligibility, and informs the primary care reimbursement service of that recommendation. The Minister for Health has no role in the clinical decision-making process and section 6 of the Health Service Executive (Governance) Act 2013 bars the Minister from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

I am sorry again for taking so long.


Deputy Gino Kenny: That is quite a long and detailed statement. It is informative for the people who are listening. I am somewhat concerned about some of what the Minister of State said, especially at the end, that this is not expected to be available in Ireland for a further period. How long is that further period? That is slightly worrying. People have been waiting for three years for these products to be approved. It is important that people get access to these products. People are being forced abroad and to the black market. They are also self-medicating, which is not appropriate or suitable, but when one is desperate, that has to be done. Regulation is very important. Is the Minister of State saying that most of the 31 licence holders will be reimbursed? People were previously getting the licence but were not being reimbursed, which caused serious hardship for the families. I welcome that, if people are getting the licences, they will automatically be reimbursed. What people have to do is somewhat bizarre. They have to go to a different jurisdiction with a licence and bring the product back four times a year. There is no other drug in the world for which this has to be done because of the stigma and rubbish relating to cannabis. Will the Minister of State clarify when this programme will be up and running and how patients can access it? Will she address the education of consultants who prescribe these substances? How do they educate themselves and interact not only with the Department of Health but patients themselves?


Deputy Catherine Byrne: I cannot answer the second last question but I will try to read back on the script. The Minister for Health looks forward to cannabis products being available to patients living in Ireland who come within the scope of the MCAP. The Department of Health's website continues to be updated with information on the scheme as it comes available. Until such time as cannabis comes available on the Irish market for use, access programme clinicians may continue to apply for a ministerial licence to prescribe medical cannabis for an individual patient under their care. The Deputy asked when the product can come into Ireland, but I cannot answer that because it is clear from the Minister's reply that the proper legislation and the European programme must be passed first. Finding a supplier seems to be a problem as well.


Deputy Gino Kenny: There is a supplier.


Deputy Catherine Byrne: I have taken note of the Deputy's three questions and I will ask the Minister for Health, Deputy Harris, to reply to them directly. I do not want to give him any false information.

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